# K083725: Radpro Ion

- Pathway: 510(k) (Traditional)
- Applicant: Virtual Imaging, Inc.
- Decided: Jan 22, 2009 after 38 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K021049 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
2 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073543: Oec 9900 Elite, Ge Oec Medical Systems (2008) Summary page 1.

## Indications for use
The RadPro ION Mobile Fluoroscopy Systems are designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures Examples of clinical application may include cholanglography, endoscopy, urologic, orthopedic, neurologic, critical care and emergency room procedures The system may be used for other imaging applications at the physician's discretion

Source page: https://510kreport.com/device/K083725
Methodology: https://510kreport.com/methodology